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FDA 510(k)

PHARMACIA MUMPS IGG ELISA

K-Number: K897006 · 1990-07-26

ApplicantPharmacia Eni Diagnostics, Inc.
Decision Date1990-07-26
Product CodeLJY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PHARMACIA MUMPS IGG ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia Eni Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-07-26 under 510(k) number K897006. The device is classified under product code LJY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHARMACIA MUMPS IGG ELISA?

PHARMACIA MUMPS IGG ELISA is a medical device that received FDA 510(k) clearance on 1990-07-26. The listed applicant is Pharmacia Eni Diagnostics, Inc.. The 510(k) number is K897006.

When did PHARMACIA MUMPS IGG ELISA receive FDA 510(k) clearance?

PHARMACIA MUMPS IGG ELISA received FDA 510(k) clearance on 1990-07-26, under 510(k) number K897006.

Who is the listed applicant for PHARMACIA MUMPS IGG ELISA?

The FDA 510(k) record lists Pharmacia Eni Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHARMACIA MUMPS IGG ELISA?

The FDA product code for PHARMACIA MUMPS IGG ELISA is LJY.

Related Clinical Trials

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Other records listing Pharmacia Eni Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K894503GEMTAB SYSTEM

Related Devices (Code: LJY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K991274MUMPS IGG ELISA TEST SYSTEMColumbia Bioscience, Inc.K980059SERAQUEST MUMPS IGGQuest Intl., Inc.K971857MUMPS IGG ELISA TESTYGull Laboratories, Inc.K961204MUMPS IGG TESTZeus Scientific, Inc.K925209MUMPS STATBiowhittaker Molecular Applications, Inc.K923903VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSABiomerieux Vitek, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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